FDA.reportPublic FDA data

MAUDE MDR 9814914

MDR report key
9814914
Report number
2134265-2020-01899
Event key
0
Event type
3
Date of event
2020-02-18
Date received
2020-03-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JAY JOHNSON JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WOLVERINE CORONARY CUTTING BALLOON MONORAILCATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORINGBOSTON SCIENTIFIC CORPORATIONNWX385138510023659475R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-100

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT BLADE SLIGHTLY LIFTED AFTER REMOVAL. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX ARTERY. FOLLOWING PREDILITATION, A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS ADVANCED BUT WAS UNABLE TO CROSS THE TARGET LESION. INFLATION WAS PERFORMED UP TO 4 ATMOSPHERES AND UPON REMOVAL, THE EDGE OF THE BLADE WAS NOTED TO BE SLIGHTLY LIFTED. THE BLADE DID NOT DISLODGE AND THERE WAS NO DAMAGE TO THE CORONARY ARTERY. A DIFFERENT DEVICE WAS ABLE TO CROSS. NO PATIENT COMPLICATIONS WERE REPORTED.